National Consumers League

FDA issues advisory on foreign counterfeit Botox


The FDA has issued an advisory, warning consumers and healthcare professionals about counterfeit Botox that has entered the marketplace.  The outer carton of these counterfeit products appears to be the FDA approved version of Botox, but inside there is a foreign version of Botox, not approved by the FDA. These counterfeits are being sold through “blast faxes” in which a foreign company solicits sales from medical practices at very low prices. There is no indication that the FDA approved version of Botox is unsafe, but these foreign counterfeit versions are unfamiliar and untested. Medical practices should not purchase products that are unsolicited. Signs that the Botox is counterfeit include the incorrect active ingredient listed on the outer carton, or expiration dates on the outer carton that do not match the accompanying vial enclosed within. Consumers must be aware that fraudulent Botox is being widely distributed, and should take extra precaution before beginning Botox treatment. If you see any suspicious looking products please report these cases of fraud immediately to, the FDA, or call the FDA’s Office of Criminal Investigations at 1-800-551-3989 to prevent other consumers from falling victim to the same traps.